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Brexit: medicines and medical devices, what is the impact for the patient?

date:

17/04/2019

The FAMHP has worked hard in recent months to guarantee that Belgian patients will have as few disadvantages as possible from Brexit. It has also taken various initiatives to prevent medicines becoming unavailable once Brexit has been completed.The impact may be greater for medical devices, but here too, preparations have been made to limit the consequences for the patient as much as possible.

Medicines

Experts at the FAMHP have identified the medicines for which there may be availability problems after Brexit. Most of the attention here was paid to medicines for which there is no other therapeutic alternative on the Belgian market. A first analysis revealed that only a small number of products will be affected. The FAMHP has closely consulted with the affected pharmaceutical companies in recent months to ensure appropriate solutions for the products affected.

After Brexit, the United Kingdom (UK) will be considered a "third country”. This means in practice that the European Union (EU) will subject all of the medicines produced in the UK to additional controls. The FAMHP works together in a European context with the drug authorities in other member states and with the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) to ensure that the companies involved revise their licenses in a timely manner and take the actions necessary so that not only the obligatory additional controls can take place in the EU, but also that the import of the affected medicines can continue.

Brexit will also require additional inspections within the framework of clinical trials, manufacturing licenses and pharmacovigilance. The FAMHP is doing everything in its power to have the necessary personnel available on time to be able to perform these activities in an efficient manner. The FAMHP has also investigated which actions are necessary to ensure that the consequences of the Brexit do not endanger the continuity of current clinical trials.

Medical Devices

The EU will also consider the UK as a "third country” after Brexit when it comes to medical devices.

This means that British companies must mandate an authorized party to sell medical devices on the European market. In addition, medical devices that require a CE certificate for sale must have a CE certificate issued by an institution registered in one of the European member states. The four registered British institutions, the BSI (0086), Lloyd’s Register Quality Assurance Ltd ( 0088), SGS United Kingdom Limited (0120) and UL International (0843) may no longer issue CE certificates for the European market after Brexit. CE certificates issued in the past will no longer be valid. The registered institutions and affected manufacturers are working at this time on making their CE certificates compliant. If the UK leaves the EU without a withdrawal agreement, manufacturers who do not receive a (new) certificate from a registered institution from the EU27 will no longer be able to legally sell their products in the EU.

Further information

The FAMHP has compiled a list of frequently asked questions about various topics such as the availability of medicines and medical devices, travelling with medicines and ordering products from the UK.